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NCT Number: NCT06364644

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for Health Equity, Baltimore, Maryland, United States

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About this study

This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:

  • Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.
  • Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas:
  • Reinforcing patient education about disease self-management
  • Helping patients access care and addressing barriers to care and treatment
  • Serving as facilitators and navigators to clinical care, social services, and other community resources
  • Providing encouragement and support to engage, activate, and empower patients and their support systems
  • Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County
  • Low socioeconomic status (SES) by high Area Deprivation Index (ADI) [>75th percentile for the state of Maryland] plus low income)
  • Type 2 diabetes
  • Obesity (BMI≥30 kg/m^2)

Exclusion criteria

  • Age < 30 or >70 years
  • Prevalent heart failure
  • Uncontrolled glycemia (blood glucose <60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%)
  • Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)
  • Known coronary artery disease (unless < 50% stenosis by angiography)
  • Moderate or severe valvular heart disease
  • Serious medical conditions limiting life expectancy or requiring active management
  • Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).
  • Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
  • End-stage renal disease
  • Current participation in another behavior change program
  • Active alcohol or substance abuse disorder
  • Already engaging in regular exercise with more than 60 minutes of moderate [3-6 METS] to vigorous [>6 METS] physical activity per week
  • Active pregnancy
  • Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test

Treatment and study plan

Community Champions

Behavioral

The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.

Other names: Multi-level intervention

Homegrown Heroes

Behavioral

Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.

Other names: Education plus access to community exercise facility

Primary outcomes

  1. Change in fitness as assessed by the 6 minute walk test

    Time frame: Baseline and 6 month follow up

    Total distance walked in the 6 minutes walk test in meters

Secondary outcomes

  1. Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)

    Time frame: Baseline and 6 month follow up

    Percent change from baseline in hs-cTnT

  2. Change in hemoglobin A1c

    Time frame: Baseline and 6 month follow up

    Absolute change from baseline in hemoglobin A1c

  3. Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.

    Time frame: Baseline, 6 month follow up, 12 month follow up

    The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive/Careless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation/Orientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124.

  4. Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)

    Time frame: Baseline, 6 month follow up, 12 month follow up

    The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.

  5. Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test

    Time frame: Baseline, 6 month follow up, 12 month follow up

    The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease.

  6. Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)

    Time frame: Baseline, 6 month follow up, 12 month follow up

    The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes.

    The MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity.

  7. Change in weight (kgs)

    Time frame: Baseline and 6 month follow-up

    Change from baseline in weight (kgs)

  8. Change in BMI

    Time frame: Baseline and 6 month follow-up

    Change from baseline in BMI (Kg/m^2).

  9. Change in hip and waist circumference (centimeters)

    Time frame: Baseline and 6 month follow up

    Change from baseline in hip and waist circumference (centimeters)

  10. Change in Metabolic Syndrome Severity Z score

    Time frame: Baseline and 6 month follow up

    Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity.

  11. Change in self-management as assessed by the Patient Activation Measure (PAM-13).

    Time frame: Baseline, 6 month follow up,12 month follow up

    The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action.

  12. Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10

    Time frame: Baseline, 6 month follow up,12 month follow up

    The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes.

  13. Change in blood pressure (systolic and diastolic (mmHg))

    Time frame: Baseline and 6 month follow up

    changes in blood pressure from baseline

  14. Change in cardiac biomarker, gal-3

    Time frame: Baseline and 6 month follow up

    Percent change from baseline in gal-3

  15. Change in cardiac biomarkers, NT-proBNP

    Time frame: Baseline and 6 month follow up

    Percent change from baseline in NT-proBNP

  16. Change in post-walk Borg dyspnea scale

    Time frame: Baseline and 6 month follow up

    Changes in post-walk Borg dyspnea scale which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"); higher score worse breathing difficulty. Measured in a subset of the population.

  17. Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)

    Time frame: Baseline and 6 month follow up

    Change in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test in a subset of the population.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiadi Ndumele, MD, PhD

CONTACT

[email protected]

4105022319

Perri Carroll, MPH

CONTACT

[email protected]

4436927272

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)

Acronym: UNLOAD-HF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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